Biocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials
Biocare Medical is recalling a single lot of Mach 4 Mouse Probe vials that may be mislabeled as HRP-Polymer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a labeling error that could affect diagnostic accuracy, fitting the criteria for a moderate severity score.
Plain-English summary
Biocare Medical, LLC is recalling a single lot (082715) of its Mach 4 HRP Polymer kit. The recall involves 93 units of the Mach 4 Mouse Probe vial, which may have been mislabeled as HRP-Polymer. The product is an immunohistochemistry reagent intended for in vitro use in detecting specific antibodies on formalin-fixed, paraffin-embedded tissues.
The recall was initiated because some vials within the identified lot may have incorrect labeling. The affected lot has an expiry date of 01/2017. The product was distributed nationwide in the United States to the states of Kansas, California, Arizona, Oregon, Florida, Colorado, Massachusetts, Kentucky, New York, Illinois, Missouri, North Carolina, Texas, Pennsylvania, Oklahoma, South Carolina, Tennessee, and Georgia, as well as to Hungary, Canada, and Bolivia.
Users of the product should stop using the affected vials and contact Biocare Medical for further instructions. The mislabeling could lead to the use of the wrong reagent in immunohistochemistry procedures, potentially affecting the accuracy of diagnostic results.
The recalled product
- Product
- Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabb
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number 082715
- Expiry 01/2017.
Distribution
Related recalls
Same manufacturer · Biocare Medical, LLC
See all →- ModerateBiocare Medical Recalls IHC Kits Due to Potential Staining Failure
FDA (Devices) · 2024-11-13
- HighBiocare Medical IntelliPath FLX Automated Staining Instrument Recall
FDA (Devices) · 2021-04-07
- HighBiocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure
FDA (Devices) · 2020-06-17
- ModerateBiocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling
FDA (Devices) · 2018-09-26
- ModerateBiocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue
FDA (Devices) · 2018-07-11
Same hazard · mis labeling
See all →- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02